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Generated: May 28, 2017

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Details for New Drug Application (NDA): 078601

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NDA 078601 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Navinta Llc, Aurobindo Pharma Ltd, Sagent Strides, Akorn Inc, and Hospira, and is included in five NDAs. It is available from five suppliers. Additional details are available on the ROPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in ROPIVACAINE HYDROCHLORIDE is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.

Summary for NDA: 078601

Formulation / Manufacturing:see details

Pharmacology for NDA: 078601

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 078601

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ropivacaine hydrochloride
SOLUTION;INJECTION 078601 ANDA Sandoz Inc 0781-3140 0781-3140-14 5 CARTON in 1 BOX (0781-3140-14) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3140-30) > 30 mL in 1 VIAL, SINGLE-DOSE
ropivacaine hydrochloride
SOLUTION;INJECTION 078601 ANDA Sandoz Inc 0781-3142 0781-3142-14 5 CARTON in 1 BOX (0781-3142-14) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3142-80) > 20 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength150MG/30ML (5MG/ML)
Approval Date:Jul 17, 2014TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength200MG/20ML (10MG/ML)
Approval Date:Jul 17, 2014TE:APRLD:No

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